ISRCTN38375681已完成2 期
A two-arm phase II randomised trial of intermittent chemotherapy plus continuous cetuximab and of intermittent chemotherapy plus intermittent cetuximab in first line treatment of patients with K-ras-normal (wild-type) metastatic colorectal cancer
Medical Research Council (MRC) (UK)0 个研究点目标入组 130 人开始时间: 2007年1月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
研究概览
简要总结
2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24703531 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Amended as of 17/02/2009:
- •1. Written informed consent
- •2. Consent for screening of an archival formalin-fixed paraffin embedded (FFPE) tumour block for determination of K-ras status, with only patients with only K-raswt tumours being eligible for randomisation
- •3. Once K-raswt status confirmed, written informed consent for participation in the trial
- •4. Patients at least 18 years or over, either sex
- •5. Confirmed colorectal adenocarcinoma:
- •5.1. Either previous or current histologically-confirmed primary adenocarcinoma of colon or rectum, together with clinical or radiological evidence of current advanced and/or metastatic disease, or
- •5.2. Histologically/cytologically-confirmed metastatic adenocarcinoma, together with clinical and/or radiological evidence of colorectal primary tumour
- •6. Inoperable metastatic or locoregional disease
- •7. Patients with potentially resectable liver metastases are eligible (see exclusion criteria)
- •8. Unidimensionally measurable disease (Response Evaluation Criteria in Solid Tumours [RECIST] criteria). Baseline computed tomography (CT) scan must be performed within 4 weeks prior to treatment
- •9. No previous systemic palliative chemotherapy for metastatic disease
- •10. Adjuvant chemotherapy with 5FU +/- FA, capecitabine or irinotecan may have been given, if completed greater than 1 month prior to trial entry
- •11. Chemoradiotherapy with 5FU +/- FA or capecitabine for rectal cancer may have been given, if completed greater than 1 month prior to trial entry
- •12. World Health Organization (WHO) performance status (PS) 0, 1 or 2 and considered by responsible consultant to be fit to undergo combination chemotherapy
- •13. Baseline laboratory tests (within 1 week prior to randomisation):
- •13.1. Neutrophils greater than or equal to 1.5 x 10^9/l and platelet count greater than or equal to 100 x 10^9/l
- •13.2. Serum bilirubin less than or equal to 1.25 x upper limit of normal (ULN), alkaline phosphatase less than or equal to 5 x ULN, and serum transaminase (either aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) less than or equal to 2.5 x ULN
- •13.3. Estimated creatinine clearance (Cockcroft and Gault) greater than or equal to 50 ml/min or measured glomerular filtration rate (GFR) (ethylenediaminetetraacetic acid [EDTA] clearance) greater than or equal to 50 ml/min
- •14. For women of childbearing potential, negative pregnancy test and adequate contraceptive precautions
- •15. Effective contraception for male patients if the risk of conception exists
- •16. Written informed consent to allow pathological material to be analysed for estimated glomerular filtration rate (EGFR) status, even if this is already known
- •Initial information at time of registration:
- •1. Patients at least 18 years or over
- •2. Confirmed colorectal adenocarcinoma:
- •2.1. Previous or current histologically-confirmed primary adenocarcinoma of colon or rectum, together with clinical or radiological evidence of current advanced and/or metastatic disease
- •2.2. Histologically/cytologically-confirmed metastatic adenocarcinoma, together with cli
排除标准
- •Amended as of 17/02/2009:
- •1. Patients who have a confirmed K-ras mutation in their tumour post screening
- •2. Patients who are receiving combination chemotherapy prior to the planned resection of operable liver metastases (defined as less than 4 unilobar liver metastases, each less than 4 cm in size and without major vascular involvement). Patients outside these criteria are of uncertain operability and are eligible.
- •3. Patients who have received any prior chemotherapy with oxaliplatin
- •4. Patients who are unfit for the chemotherapy regimens in this protocol, e.g.:
- •4.1. Severe uncontrolled concurrent medical illness (including poorly controlled angina or very recent myocardial infarction [MI], i.e. in previous 12 weeks) likely to interfere with protocol treatments
- •4.2. Any psychiatric or neurological condition which is felt likely to compromise the patient's ability to give informed consent or to comply with oral medication
- •4.3. Partial or complete bowel obstruction
- •4.4. Pre-existing neuropathy (greater than Grade 1)
- •5. Patients requiring ongoing treatment with a contraindicated concomitant
- •6. Patients with another previous or current malignant disease which, in the judgement of the treating investigator, is likely to interfere with COIN-B treatment or assessment of response
- •7. Patients with known hypersensitivity reactions to any of the components of the study treatments
- •8. Patients with brain metastases
- •9. Patients with a personal or family history of dihydropyrimidine dehydrogenase (DPD) deficiency, or with proven DPD deficiency
- •Initial information at time of registration:
- •1. Patients who are receiving combination chemotherapy prior to the planned resection of operable liver metastases (defined as less than four unilobar liver metastases, each less than 4 cm in size and without major vascular involvement). Patients outside these criteria are of uncertain operability and are eligible
- •2. Patients who have received any prior chemotherapy with oxaliplatin
- •3. Patients who are unfit for the chemotherapy regimens in this protocol, e.g.:
- •3.1. Severe uncontrolled concurrent medical illness (including poorly controlled angina or very recent Myocardial Infarction (MI), i.e. in previous 12 weeks) likely to interfere with protocol treatments
- •3.2. Any psychiatric or neurological condition which is felt likely to compromise the patient's ability to give informed consent or to comply with oral medication
- •3.3. Partial or complete bowel obstruction
- •3.4. Pre-existing neuropathy (more than Grade one)
- •4. Patients requiring ongoing treatment with a contraindicated concomitant medication
- •5. Patients with another previous or current malignant disease, which, in the judgement of the treating investigator, is likely to interfere with COIN-B treatment or assessment of response
- •6. Patients with known hypersensitivity reactions to any of the components of the study treatments
- •7. Patients with brain metastases
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